Optimizing Chronic Pain Management Through Remote Monitoring: A Proof-of-Concept Study Using a Digital Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain Level: Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
A single site, proof-of-concept prospective behavioral interventional study testing remote monitoring among people living with chronic pain. The study is a single arm study. The duration of the study will be 12-18 months, enrolling 100 and following up to six months post enrollment/ baseline. A convenience sample of 50 patients with CP meeting the inclusion criteria will participate in a 3 to 6 month remote monitoring program utilizing FitCam. Since the time period to conduct this study is 12 months.
FitCam portal/ app will be utilized for the intervention and the outcome will be recorded to observe if remote monitoring has an affect in the health outcome compared to baseline health quality of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form (ICF)
- •Age: Adults aged 18 years or older
- •Ability to comply with the study protocol, including having a smartphone and being able and willing to access the application on a regular basis. To use all functionalities of the application, the user's smartphone must comply with the minimum system requirements (Android version 8.0 or above, iOS version 13.0 or above)
- •Have a valid email address
- •Have a valid phone number
- •Diagnosis Codes:
- •Patients with a confirmed diagnosis of Chronic Pain Syndrome based on ICD-10 code G89.4 as primary diagnosis.
- •■ Including Fibromyalgia M79.7
- •Patient with a confirmed secondary diagnosis
- •Back Pain M54.5
- •Neck Pain M54.2
- •Joint Pain M25.5
- •Medications: N/A
- •Test/Lab results: N/A
- •Study sites: Hackensack Meridian Health Neuroscience Institute located at 650 From Road, Suite 506, Paramus, NJ, 07652
- •Service: Outpatient
排除标准
- •Age: Patients below 18 years of age
- •Unable or unwilling to provide informed consent
- •Presence of an active diagnosis of a comorbid cognitive impairment such as dementia or mild cognitive impairment
- •Lack of access to a smartphone device or inability to demonstrate proficiency in downloading and using mobile applications
- •Physical limitations that prevent participation in a basic home exercise program
- •Considered by the investigator to have a condition that precludes safe or active participation in the trial
研究组 & 干预措施
Remote monitoring
Remote monitoring using a phone application, an exercise routine, and regular check-ins with a healthcare provider.
干预措施: Remote application intervention (Behavioral)
结局指标
主要结局
Pain Level: Numerical Pain Rating Scale (NPRS)
时间窗: Baseline and once a month for up to 6 months
The NPRS is an 11-point scale used to measure pain intensity, where 0 signifies no pain and 10 represents the most severe pain imaginable.
Pain Level: Patient Global Impression of Change (PGIC)-pain
时间窗: Baseline and once a month for up to 6 months
The PGIC-pain is a 7-point scale that reflects a patient's perception of overall progress. Patients indicate their level of change with options ranging from "very much improved" to "very much worse," including intermediate levels such as "much improved," "minimally improved," "no change," "minimally worse," and "much worse."
Mood: Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline and once a month for up to 6 months
The PHQ-9 is a brief, nine-item assessment tool designed to identify potential depression in patients. It assesses the frequency of depressed mood and anhedonia over the past two weeks. Each item is scored on a scale from 0 to 3, where 0 means "Not at all" and 3 means "Nearly every day", resulting in a total score ranging from 0 to 27. Higher scores indicate a greater likelihood of depression.
Mood: Patient Health Questionnaire-2 (PHQ-2)
时间窗: Baseline and once a month for up to 6 months
The Patient Health Questionnaire-2 (PHQ-2) is a brief, two-item screening tool designed to identify potential depression in patients. It assesses the frequency of depressed mood and anhedonia (loss of interest or pleasure) over the past two weeks. Each item is scored on a scale from 0 to 3, where 0 means "not at all" and 3 means "nearly every day," resulting in a total score ranging from 0 to 6. Higher scores indicate a greater likelihood of depression, and a score of 3 or higher typically warrants further evaluation with the PHQ-9 or a more comprehensive clinical assessment.
Mood: PGIC-mood
时间窗: Baseline and once a month for up to 6 months
The PGIC-mood is a 7-point scale that reflects a patient's perception of overall progress. Patients indicate their level of change with options ranging from "very much improved" to "very much worse," including intermediate levels such as "much improved," "minimally improved," "no change," "minimally worse," and "much worse."
Sleep-Numeric Rating Scale (NRS)
时间窗: Baseline and once a month for up to 6 months
The Sleep-NRS is a 0 to 10 scale that assesses sleep quality from the previous night, where 0 represents the poorest sleep and 10 signifies the best possible sleep. It is commonly used to evaluate patients' overall sleep quality.
PGIC-sleep
时间窗: Baseline and once a month for up to 6 months
The PGIC-sleep is a 7-point scale that reflects a patient's perception of overall progress. Patients indicate their level of change with options ranging from "very much improved" to "very much worse," including intermediate levels such as "much improved," "minimally improved," "no change," "minimally worse," and "much worse."
次要结局
- Multidimensional Scale of Perceived Social Support(Baseline and once a month for up to 6 months)